MDCG 2025-1: Procedure Form for Updating the European Medical Device Nomenclature (EMDN)

In January 2025, the Medical Devices Coordination Group (MDCG) published document MDCG 2025-1, which approves the ad-hoc procedure form for submitting proposals related to updating the European Medical Devices Nomenclature (EMDN). The MDCG is a body made up of representatives from all the Member States of the European Union, chaired by a representative of the European Commission.

This document aims to provide a clear procedure for National Competent Authorities (NCA) and Notified Bodies (NB) for submitting requests to update codes, mainly in the UDI-DI module of the EUDAMED database. The need for an ad-hoc procedure arises in cases where existing codes are not suitable for categorizing or registering new medical devices.

Please note that this document is not a publication of the European Commission, nor does it reflect its official position. Any binding interpretation of European Union legislation can only be provided by the Court of Justice of the European Union. The opinions expressed in the document are not binding and only serve as guidelines for stakeholders involved in the medical device registration process.

The form includes mandatory fields, such as the identification of the device or technology in question, a detailed description of the device, an indication of whether it is considered a new device, among others. Interested companies should send their proposals to the following address SANTE-EMDN@ec.europa.euas instructed in the form.

For more details, see the full document.